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EC number: 293-346-9 | CAS number: 91078-64-7
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- November 19, 1996 until December 20, 1996.
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- Reliability of original study is 1
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Results of guinea pig maximisation test were available.
Test material
- Reference substance name:
- Sodium diisobutylnaphthalenesulphonate
- EC Number:
- 248-326-4
- EC Name:
- Sodium diisobutylnaphthalenesulphonate
- Cas Number:
- 27213-90-7
- Molecular formula:
- C18H24O3S.Na
- IUPAC Name:
- sodium 2,3-diisobutylnaphthalene-1-sulfonate
- Test material form:
- solid: particulate/powder
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright White
- Sex:
- female
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- intradermal induction with 0.5 % test substance
percutaneous induction with a 50 % test substance preparation
Challenge
- Route:
- other: percutaneous induction.
- Vehicle:
- water
- No. of animals per dose:
- The study was performed on 20 guinea pigs in the test group and 10 animais in each of control groups 1 and 2.
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- test substance 25% in aqua bidest.
- No. with + reactions:
- 5
- Total no. in group:
- 19
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- test substance 25% in aqua bidest.
- No. with + reactions:
- 3
- Total no. in group:
- 18
Any other information on results incl. tables
The number of animais with skin findings after the ist challenge and after the 2nd challenge is summarized in the following table:
|
1st challenge |
2st challenge |
||
test substance 25% in aqua bidest. |
test substance 25% in aqua bidest. |
|||
After 24 hours |
After 48 hours |
After 24 hours |
After 48 hours |
|
Control group 1 |
0/10 |
0/10 |
0/10 |
0/10 |
Control group 2** |
no application of test substance |
0/7 |
0/7 |
|
Test group** |
5/19 |
3/18 |
0/17 |
0/17 |
x/y: number of positive reactions/number of animais tested (reading at 24 h and/or 48 h after the removal of the patch)
**: 3 test group animais and 3 animais of control group 2 died 18, 21, 22, 23 or 25 days after the beginning of the study. Macroscopic examination revealed that the cause of death was not substance related.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified as a skin sensitiser according to the CLP Regulation (EC) No.1272/2008
- Conclusions:
- not a skin sensitiser
- Executive summary:
The substance was tested for its sensitizing effect an the skin of the guinea pig in the Maximization Test based on the method of Magnusson and Kligman. The intradermal induction with 0.5 % test substance preparations caused slight to well-defined signs of 5km irritation or necrotic skin changes in test group animais. After the percutaneous induction with a 50 % test substance preparation incrustation, partially open (caused by the intradermal induction; could be observed in addition to well-defined erythema and slight edemna or necrotic skin changes (caused by the * intradermal induction) and slight edema in test group animais. Two challenges were performed 14 and 21 days after the percutaneous induction.
After the first challenge with a 25 % test substance preparation very slight to well-defined 5km reactions could be observed in test group animais. The second challenge with a 25% test substance preparation did not cause any skin reaction.
Based on the results of this study it was concluded that the test item does not have a sensitizing effect on the skin of the guinea pig in the Maximization Test under the test conditions chosen.
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